shrutisancheti
Starting to get Involved
Hello.
I have a question regarding "Medical device upgrade at user facility" as per US FDA requirements.
Here, upgrade means addition of one modality (e.g. CT scan) to the already existing modality (e.g. SPECT), i.e. change in safety and effectiveness of the overall device.
If manufacturer already holds a 510(k) approval for SPECT and SPECT/CT models with same configuration, will he be able to modify SPECT at user facility to SPECT/CT?? If yes, please help explaining how.. Also, if any guidance document available by US FDA, will be very helpful.
Waiting for reply.
Thank you in advance.
Best regards,
Shruti
I have a question regarding "Medical device upgrade at user facility" as per US FDA requirements.
Here, upgrade means addition of one modality (e.g. CT scan) to the already existing modality (e.g. SPECT), i.e. change in safety and effectiveness of the overall device.
If manufacturer already holds a 510(k) approval for SPECT and SPECT/CT models with same configuration, will he be able to modify SPECT at user facility to SPECT/CT?? If yes, please help explaining how.. Also, if any guidance document available by US FDA, will be very helpful.
Waiting for reply.
Thank you in advance.
Best regards,
Shruti